MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 8 5MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number 1516-40-805

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Edema (1820); Muscular Rigidity (1968); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Records indicate patient received a left attune total knee arthroplasty.The records do not provide any indication of patient harm or product failure, nor report of a knee revision.Doi: (b)(6) 1957; dor: unknown; (left knee).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.H10 additional narrative: added: h6 (patient code).

• Brand Name: ATTUNE PS FB INSRT SZ 8 5MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9402547
• MDR Text Key: 168855200
• Report Number: 1818910-2019-119624
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295050346
• UDI-Public: 10603295050346
• Combination Product (y/n): N
• PMA/PMN Number: K111433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: 1516-40-805
• Device Catalogue Number: 151640805
• Device Lot Number: C35195
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE FB TIB BASE SZ 8 CEM.; ATTUNE PS FEM LT SZ 8 CEM.; COMPETITOR'S BONE CEMENT.; ATTUNE FB TIB BASE SZ 8 CEM; ATTUNE PS FEM LT SZ 8 CEM; COMPETITOR'S BONE CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR